Microbiology FDA 483 (Panacea Biotec): Procedures for the cleaning and maintenance of equipment are deficient

Observation

Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.

Facility Type

Sterile & Non-Sterile Manufacturing

Firm / Company

Panacea Biotec Pharma Ltd.

System

Quality System, Laboratory Controls, Facilities and Equipment System

Details

Specifically, cleaning procedures for the cleaning of *** RAB/RAB and the aseptic area do not contain enough detail to ensure reproducibility between operators.

 

(A) The aseptic filling area consists of *** RAB *** through RAB *** , as well as RAB *** and RAB *** and the surrounding Grade B area. The associated cleaning procedure do not specify instructions for cleaning/disinfecting from clean to dirty areas, moving from inside to outside when cleaning equipment or the order in which to clean the *** RAB/RAB units. During the review of cleaning practices performed on Oct. 8, 2023, observed the operators varying the order of cleaning inside a specific RABs unit as well as operators cleaning the aseptic area, switching to cleaning the RABs/RAB unit, then back to cleaning of the aseptic area.

 

(B) The *** RAB*** and *** RAB*** units are located approximately *** off the floor. During the review of the cleaning which took place on Oct 8, 2022, the operators did not clean below this area.

 

(C) The RAB *** were manually manipulated during the *** of the *** RAB/RAB unit performed on Oct. 8, 2022. The procedure states to “ensure that the *** RAB and RAB *** are exposed manually or with the help of *** towards *** for complete disinfection”. Details for duration how to manipulate the *** during *** is not included in the procedure and it is unclear how the inconsistent manual manipulations could affect the disinfectant.

 

(D) Cleaning operators were observed standing on *** during cleaning. These same *** are used to hold *** bottles, wipes, environmental monitoring plates and off-line NVP counters during aseptic filling. ***, dated Feb. 15, 2023, failed due to the operator touching the *** and not sanitizing his gloves during filtration.

Record Date

10/2023

FEI Number

3007187282

Country

India

Citation Type

483

Audit Duration (Days)

8

Investigators

Sandra A Boyd, Muna Algharibeh

More observations from same firm / company

Microbiology FDA 483 (Panacea Biotec): Procedures designed to prevent microbiological contamination for are not established, written and followed (Sterile Drug)

Microbiology FDA 483 (Panacea Biotec): Deficient Aseptic processing areas for environmental monitoring conditions

Microbiology FDA 483 (Panacea Biotec): Procedures to prevent microbiological contamination did not include adequate validation of the aseptic process

Microbiology FDA 483 (Panacea Biotec): Failure to thoroughly review any unexplained discrepancy to meet any of its specifications

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Disclaimer: The purpose of this article is to provide helpful information on FDA 483s related to microbiological issues. This article represents 483 information in Tabular form for quick access and easy navigation. Information for this article is derived from “Form FDA 483” (Inspectional Observation). This article is not intended to replace the information provided by the FDA, nor is it guaranteed to be complete, always refer official FDA site for details.

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Alarm 1 Aseptic Behavior 30 Aseptic Technique 49 Autoclave 1 Biological Indicator 1 Building Maintenance 6 Calibration 1 Clean Room 15 Clean Room Practices 36 Cleaning and Sanitization 29 Cleaning Validation 1 Computerized System 4 Contamination 13 Contemporaneous Verification 1 Data Integrity Issue 10 Disinfectant Efficacy 2 Disinfection 15 Drug Product 1 Endotoxin 1 Environment monitoring 16 Equipment Cleaning 6 Equipment Operation 13 Facilities And Equipment System 13 Facility Design 5 Follow-Up Findings 2 General Cleaning 3 Good documentation Practices 4 Gowning 3 HEPA 4 Hold Time Study 2 HVAC 6 Influx of lesser quality air 1 Investigation 12 Investigation inadequate 5 Investigation incomplete 3 Laboratory Controls 17 Laboratory Practice 16 Maintenance 10 Manufacturing control 9 Media Fill 15 Method Transfer 2 Method Validation 5 Microbial Identification 1 Microbiological Contaminationn 10 No Procedure followed 14 Non-Conformance 1 OOS 5 Personnel Monitoring 3 Procedure 32 Qualification 32 Quality System 33 Risk assessment 6 Service Vendor Audit 1 Smoke studies 14 Specifications 5 Stability Study 2 Sterile Drug Products 5 Sterility Testing 1 sterilizati 2 Sterilization 3 Suitability 1 test procedure 0 Test Procedure (SOP) 10 Trends 1 Usage log 1 Validation 37 Visual Inspection 1 Warehouse 2 Water System 1

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